(178 days)
Tenax White Posts are for use where ever endodontic posts are required and where esthetic considerations and/or where known allergies to metals are of concern.
Not Found
This is a 510(k) submission letter, not a study or device performance report. Therefore, the requested information regarding acceptance criteria, study details, and performance metrics for a medical device is not available in the provided text.
The document states that the FDA has reviewed the Section 510(k) notification for the "Tenax White Post" and determined it to be substantially equivalent to devices marketed prior to May 28, 1976. This means the device is cleared for market based on its similarity to existing legal devices, rather than through a new clinical trial demonstrating performance against specific acceptance criteria.
The "Indications for Use" section (page 2) describes the intended purpose of the Tenax White Posts ("for use where ever endodontic posts are required and where esthetic considerations and/or where known allergies to metals are of concern"), but it does not provide any performance data or acceptance criteria.
Therefore, I cannot provide the requested information as it is not present in the provided document.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 4 2000
H.J. Vogelstein Mr. Official Correspondent Coltène/Whaledent Inc. 750 Corporate Drive Mahwah, New Jersey 07430-2009
K993545 Re : Tenax White Post Trade Name: Requlatory Class: I Product Code: ELR Dated: January 14, 2000 Received: January 18, 2000
Dear Mr. Vogelstein:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 — Mr. Vogelstein
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Coltène/Whaledent Inc.
510(k) Submission Tenax White Post
Indications for Use
Tenax White Posts are for use where ever endodontic posts are required and where
esthetic considerations and/or where known allergies to metals are of concern..
Susan Runos
(Division Sign-Off) Division of Dental, Infection Control, and General Hospitel gevices 510(k) Number -
§ 872.3810 Root canal post.
(a)
Identification. A root canal post is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be cemented into the root canal of a tooth to stabilize and support a restoration.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.